Last Updated on October 2, 2024 by The Health Master
New Delhi: Drug majors Dr. Reddy’s Laboratories and Sun Pharma are recalling different products in the US market for manufacturing issues, according to the US Food and Drug Administration (USFDA).
Dr. Reddy’s Laboratories
As per the enforcement report by the US health regulator, the US-based arm of Dr. Reddy’s Laboratories is recalling over 48,000 cartons of a drug used to treat sneezing, runny, or stuffy nose.
It is recalling 25,176 cartons of 30-count tablets and 22,968 cartons of 20-count tablets.
According to USFDA, Dr. Reddy’s Laboratories is recalling the affected lot due to “failed stability specifications”.
New Jersey-based Dr. Reddy’s Laboratories, Inc initiated the Class III recall on November 21 this year.
As per the USFDA, a Class III recall is initiated in a “situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
Sun Pharmaceuticals
The health regulator further said the US-based arm of Sun Pharma is recalling 14,064 cartons of a medication to treat erosive esophagitis or heartburn caused by gastroesophageal reflux disease (GERD).
The company is recalling the affected lot, produced at its Mohali plant, due to “discoloration”, it added.
Sun Pharmaceutical Industries Inc commenced the Class II voluntary recall in the US on July 25 this year.
As per USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
According to industry estimates, the US generic drug market was estimated at around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products.
Drug recall: FDA issues nationwide recall for Ferric Carboxymaltose
Drug recall: These drugs recalled by Aurobindo for this reason
Drug recall: These products recalled by Dr Reddy’s, Cipla, and Aurobindo
Drug recall: Sodium Bicarbonate Injection recalled due to this reason
Drug recall: Acyclovir Sodium Injection recalled due to this reason
Drug recall: Zydus, Lupin recall products due to this issue
USFDA gives nod for Diclofenac Sodium topical solution
IPC releases amendment list for IP 2022, details here
NPPA releases 2nd list with draft ceiling prices for 43 formulations
USFDA gives approval for Venlafaxine ER tablets
Gujarat FDCA launches online licensing system for cosmetics
IPC to digitize Indian Pharmacopoeia (IP) soon
DCOIWA’s state-wise training program for drug regulators begins
NPPA fixes Retail Price of one formulation: November 2022
CDSCO gives approval for this Anti-diabetic drug
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: